Home / Recalls / Northgate Technologies, Inc. / Z-1148-2021

Z-1148-2021 Class II Terminated

Recalled by Northgate Technologies, Inc. — Elgin, IL

Recall Details

Product Type
Devices
Report Date
March 3, 2021
Initiation Date
January 15, 2021
Termination Date
October 31, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
45 units

Product Description

Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 710300 - Product Usage: designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope.

Reason for Recall

An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device.

Distribution Pattern

US Nationwide distribution in the states of FL and OH.

Code Information

Lot Codes: 93830JEK to 93854JEK; 93899LEK to 93908LEK; 93909LEK to 93918LEK

Other recalls by Northgate Technologies, Inc.

  • Z-1235-2022 Class II — AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe (April 13, 2022)
  • Z-0333-2022 Class II — Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF M005 (October 25, 2021)
  • Z-1147-2021 Class II — ConMed 50L abdominal insufflator, Catalog Number 72-00258-0 / GS2000 - Product U (January 15, 2021)
  • Z-1885-2020 Class II — ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Technologies, America ( (March 10, 2020)
  • Z-1884-2020 Class II — AUTOLITH URO-TCH 9FR PROBE 54CM; NTI Catalog Number 9-203-0543 - Product Usage: (March 10, 2020)
  • Z-1883-2020 Class II — Probe, 9 FR AUTOLITH; NTI Catalog Number 9-900-54 - Product Usage: Probes are us (March 10, 2020)
  • Z-0073-2018 Class II — Electrohydraulic lithotripter probe, 1.9 FR 375 cm, Model 9-195-371DS used with (May 24, 2017)
  • Z-0866-2017 Class II — Insufflator, laparoscopic The ConMed GS2000, Smith & Nephew 500, Novadaq 50L (November 21, 2016)